NCT01043380已完成4 期
Plaque REgression With Cholesterol Absorption Inhibitor or Synthesis Inhibitor Evaluated by IntraVascular UltraSound
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 245
- 试验地点
- 1
- 主要终点
- Absolute change from baseline to follow-up in percent atheroma volume (PAV) in the target lesion
研究概览
简要总结
The purpose of this study was to evaluate the difference in the effect of coronary plaque regression (as measured by intravascular ultrasound [IVUS] imaging) between cholesterol absorption inhibitor and cholesterol synthesis inhibitor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent,
- •30 to 85 years old,
- •Plan to undergo PCI and LDL-C >= 100 mg/dL
排除标准
- •Familial hypercholesterolemia
- •Being treated with Zetia (Ezetimibe)
- •Being treated with Fibrates
- •Renal insufficiency (serum creatinine >= 2.0 mg/dl)
- •Altered hepatic function (serum aspartate aminotransferase or alanine aminotransferase >= 3-folds of standard value in each institute)
- •Undergoing hemodialysis or peritoneal dialysis
- •Allergic to Lipitor and/or Zetia
- •Severe underlying disease
- •Lack of decision-making capacity
- •Recognized as inadequate by attending doctor
研究组 & 干预措施
LZ group
Experimental
干预措施: Combination therapy with Lipitor [Atorvastatin] and Zetia [Ezetimibe] (Drug)
L group
Active Comparator
干预措施: Lipitor (Atorvastatin) monotherapy (Drug)
结局指标
主要结局
Absolute change from baseline to follow-up in percent atheroma volume (PAV) in the target lesion
时间窗: before randomization & 9-12 months after randomization
次要结局
- Percentage changes from baseline to follow-up in serum lipids(before randomization & 9-12 months after randomization)
- Correlation between regression of coronary plaque and inflammatory markers (white blood cell count and hs-CRP)(before randomization & 9-12 months after randomization)
- Changes in hs-CRP from baseline to follow-up(before randomization & 9-12 months after randomization)
- Change and percentage change from baseline to follow-up in the MLD and %DS of the PCI target lesion(before randomization & 9-12 months after randomization)
- Percentage change from baseline (before randomization) to follow-up (9-12 months after randomization) in the atheroma volume(before randomization & 9-12 months after randomization)
- Change and percentage change from baseline to follow-up in the minimum lumen diameter (MLD) and percent diameter stenosis (%DS)(before randomization & 9-12 months after randomization)
- Correlation between regression of coronary plaque and serum lipids profiles(before randomization & 9-12 months after randomization)
- Change and percentage change from baseline to follow-up in the PV of the PCI target lesion(before randomization & 9-12 months after randomization)
- MACE (cardiac death, non-fatal Q wave and/or non-Q wave myocardial infarction, target vessel revascularization [percutaneous coronary intervention or coronary artery bypass grafting])(before randomization & 9-12 months after randomization)
- All-cause death(before randomization & 9-12 months after randomization)
- Safety (Adverse events, subjective symptoms/objective findings, physical tests), blood tests [hematology, clinical chemistry, glucose metabolism test], urinalysis)(before randomization & 9-12 months after randomization)
研究者
Hisao Ogawa
Professor
Kumamoto University
研究点 (1)
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